# K963664: Dental Handpiece and Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Filmtech, Inc.
- Decided: Oct 24, 1996 after 41 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900093 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900093: Disposa-Shield (TM) Infection Control Barrier, Dentsply Intl. (1990) Summary page 1.
- K952234: Barrier All Film, Cottrell, Ltd. (1995) Summary page 1.

## Most influential descendants
- K031851: Dentiseptic HPC (2003), 0 descendants of its own

## Indications for use
Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment: * Light Handles * Chairs * Headrests * Air and Water Syringe sleeves (ties included) * Stools * X-Ray Heads * Trays

Source page: https://510kreport.com/device/K963664
Methodology: https://510kreport.com/methodology